Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2011 |
End Date: | October 2014 |
A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion
/ (VMT) including macular hole with ocriplasmin.
/ (VMT) including macular hole with ocriplasmin.
The present study is designed to assess anatomical and functional outcomes following a
single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic
vitreomacular adhesion (VMA)/ (VMT) including macular hole.
single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic
vitreomacular adhesion (VMA)/ (VMT) including macular hole.
Inclusion Criteria:
- Subjects 18 years of age or older and of either gender
- Presence of vitreomacular adhesion
- Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
- BCVA of 20/800 or better in the non-study eye
Exclusion Criteria:
- History or current evidence of proliferative retinopathy, exudative age-related
macular degeneration (AMD) or retinal vein occlusion in the study eye
- Any vitreous hemorrhage or any other vitreous opacification which precludes the
visualization of the posterior pole by visual inspection OR adequate assessment of
the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye
- Macular hole of > 400 µm diameter in the study eye
- Presence of epiretinal membrane (ERM)
- Aphakia in the study eye
- High myopia (more than 8D) in study eye
- History of rhegmatogenous retinal detachment in either eye
- History of vitrectomy in the study eye
- Previous participation in this trial or prior administration of ocriplasmin in the
study eye
We found this trial at
25
sites
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